MedPath

Dronabinol

Generic Name
Dronabinol
Brand Names
Marinol, Sativex, Syndros
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
1972-08-3
Unique Ingredient Identifier
7J8897W37S
Background

Dronabinol (marketed as Marinol) is a synthetic form of delta-9-tetrahydrocannabinol (Δ⁹-THC), the primary psychoactive component of cannabis (marijuana). THC demonstrates its effects through weak partial agonist activity at Cannabinoid-1 (CB1R) and Cannabinoid-2 (CB2R) receptors, which results in the well-known effects of smoking cannabis such as increased appetite, reduced pain, and changes in emotional and cognitive processes. Due to its evidence as an appetite stimulant and an anti-nauseant, Dronabinol is approved for use in anorexia associated with weight loss in patients with AIDS and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments .

Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the two most abundant cannabinoids found naturally in the resin of the marijuana plant, both of which are pharmacologically active due to their interaction with cannabinoid receptors that are found throughout the body . While both CBD and THC are used for medicinal purposes, they have different receptor activity, function, and physiological effects. If not provided in their activated form (such as through synthetic forms like Dronabinol or Nabilone), THC and CBD are obtained through conversion from their precursors, tetrahydrocannabinolic acid-A (THCA-A) and cannabidiolic acid (CBDA), through decarboxylation reactions. This can be achieved through heating, smoking, vaporization, or baking of dried unfertilized female cannabis flowers.

From a pharmacological perspective, Cannabis' diverse receptor profile explains its potential application for such a wide variety of medical conditions. Cannabis contains more than 400 different chemical compounds, of which 61 are considered cannabinoids, a class of compounds that act upon endogenous cannabinoid receptors of the body . The endocannabinoid system is widely distributed throughout the central and peripheral nervous system (via the Cannabinoid Receptors CB1 and CB2) and plays a role in many physiological processes such as inflammation, cardiovascular function, learning, pain, memory, stress and emotional regulation, and the sleep/wake cycle among many others . CB1 receptors are found in both the central and peripheral nervous system, and are most abundant in the hippocampus and amygdala, which are the areas of the brain responsible for short-term memory storage and emotional regulation. CB2 receptors are mainly located in the peripheral nervous system and can be found on lymphoid tissue where they are involved in regulation of immune function .

Indication

Dronabinol is indicated for the treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Associated Conditions
Anorexia, Chemotherapy-Induced Nausea and Vomiting

Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.

Phase 3
Withdrawn
Conditions
Spasticity
Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2013-06-04
Last Posted Date
2016-08-11
Lead Sponsor
GW Research Ltd
Registration Number
NCT01868048

Cannabinoids and Cerebellar-Motor Functioning

Early Phase 1
Completed
Conditions
Psychotic Disorders
Cannabis
Interventions
Drug: Placebo
First Posted Date
2013-05-14
Last Posted Date
2022-02-11
Lead Sponsor
Yale University
Target Recruit Count
57
Registration Number
NCT01853020
Locations
🇺🇸

VA Connecticut Healthcare System, West Haven, Connecticut, United States

The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes

Phase 1
Terminated
Conditions
Schizophrenia
Interventions
Other: Placebo Comparator
First Posted Date
2013-04-16
Last Posted Date
2015-09-21
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
13
Registration Number
NCT01832766
Locations
🇺🇸

University of Colorado Denver, Aurora, Colorado, United States

Combined THC and CBD Drops for Treatment of Crohn's Disease

Phase 1
Completed
Conditions
Crohn's Disease
Interventions
First Posted Date
2013-04-08
Last Posted Date
2019-03-08
Lead Sponsor
Meir Medical Center
Target Recruit Count
50
Registration Number
NCT01826188
Locations
🇮🇱

Meir Hospital, Kfar Saba, Israel

A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

Phase 1
Completed
Conditions
Cancer
Interventions
First Posted Date
2013-03-18
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
6
Registration Number
NCT01812603
Locations
🇬🇧

Bristol Haematology & Oncology Centre, Bristol, United Kingdom

🇬🇧

St James's Institute of Oncology, St James's University Hospital, Leeds, Yorkshire, United Kingdom

🇬🇧

The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, United Kingdom

and more 2 locations

A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma Patients

Phase 1
Completed
Conditions
Cancer
Interventions
Drug: Placebo
First Posted Date
2013-03-18
Last Posted Date
2022-12-20
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT01812616
Locations
🇩🇪

Klinik für Onkologie, Hämatologie und Stammzelltransplantation, Universitätsklinikum Aachen RWTH, Aachen, Germany

🇩🇪

Neurologie des Klinikums Altenburger Land, Altenburg, Germany

🇩🇪

Zentrum für Neuroonkologie der Universität Duesseldorf, Duesseldorf, Germany

and more 8 locations

Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Phase 2
Completed
Conditions
Irritable Bowel Syndrome
Interventions
Drug: Placebo
First Posted Date
2013-02-07
Last Posted Date
2013-03-14
Lead Sponsor
Michael Camilleri
Target Recruit Count
75
Registration Number
NCT01786109
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

Phase 2
Completed
Conditions
Sleep Apnea, Obstructive
Interventions
Drug: Placebo (for Dronabinol)
First Posted Date
2012-12-21
Last Posted Date
2021-07-29
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
75
Registration Number
NCT01755091
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Not Applicable
Completed
Conditions
Cannabis Dependence
Interventions
Drug: Placebo
First Posted Date
2012-12-13
Last Posted Date
2016-02-01
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
16
Registration Number
NCT01748799
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

Phase 2
Completed
Conditions
Cannabis Dependence
Interventions
Behavioral: Motivational Enhancement/Cognitive Behavioral Therapy
Drug: Placebo spray
First Posted Date
2012-12-12
Last Posted Date
2017-10-02
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
45
Registration Number
NCT01747850
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

© Copyright 2025. All Rights Reserved by MedPath